UControl Manual - Bio-Medical Instruments, Inc.
Contents
1. 12 X3 Threshold Microvolt Approximate Values 13 Sensor Use REA E 14 Care and Storage of your SySteM esrverrrrrrrerreseerereceese 16 Specifications seesesseseosoesessesessossessossesocssesoesoesessossesoessese 17 Biofeedback Equipment and Accessories sessesoessososses0 18 Limited Product Warranty e seseseseseesesoeeccesosoesesececoesosoesese 19 Repair Return FOrmM sessessescssoesessossesoessesoesoesessossesoessese 21 Quick Start Instructions Medical Precautions Before using the equipment it is recommended that a proper evaluation of the user be performed by a qualified medical practitioner This would include if relevant a proctologic urologic and or gynecological evaluation The determination of whether to use EMG feedback using this equipment must be left to the medical practitioner 1 Insert a 9 volt battery into EG the battery compartment an see page 7 for additional ama instructions DS N A 2 Set scale switch to X1 for ER incontinence or X3 for large muscle groups 1 Terminal 4 3 2 5 e Mi ABV CON BLW X1 X3 SENSOR 3 Set tone switch to CON continuous unless directed otherwise by your healthcare professional 4 Plug earphones into headphone jack if desired 5 Plug only the Thought Technology Ltd vaginal rectal or extension surface cable into sensor jack 6 Insert hand into wrist strap2. 7 Your sensor should be cleaned before its first use Follow the instructions included with the sensor WORK f N THRESHOLD 7 XML REST 2 Turn unit on by rotating on vol dial clockwise 1 Setthreshold value by rotating threshold dial to desired value M C ON VOL L K Follow your healthcare professional s treatment instructions IMPORTANT If irritation or discomfort persists discontinue use and notify your physician or health care professional immediately 3 After use e Turn unit off e Unplug sensor e Clean vaginal or rectal sensor by washing in flowing warm soapy water per instructions included with sensor e Store unit and sensor in carrying case Note If you have NOT been instructed to use a specific threshold level by your healthcare provider contact your healthcare professional for the appropriate setting Detailed Instructions Battery Installation Remove battery panel by pressing _ y on arrow and sliding panel down i Insert a rechargeable Ni Cad 9 volt battery or an alkaline battery making sure to properly connect the and on the battery to the appropriate terminal Replace battery panel cover Regular 9 volt batteries are not recommended due to short battery life If the LEDs do not illuminate replace with a new battery To prevent battery leakage remove battery when the U Control unit will n
3. to keep in mind that a very relaxed muscle should provide an EMG reading of approximately 1 3uV After use the Vaginal Sensor Rectal Sensor and Extension Surface Cable may be a potential biohazard Handle and when applicable dispose of these materials in accordance with accepted medical practice and any applicable local state and federal laws and regulations Remove batteries when the device is not being used for extended period of time Please dispose of batteries following national regulations CONTRAINDICATIONS e Not for diagnostic purposes Pregnancy Patients with limited or impaired physical and mental capacity e Bladder or Vaginal infection Menstrual period INTENDED PURPOSE Urinary Incontinence including Stress urge mixed incontinence Fecal Incontinence Muscle reeducation ADVERSE REACTIONS e There are no known adverse effects in using EMG for urinary incontinence NOTE e No preventative inspections required qualified personnel must perform maintenance e The supplier will make available upon request circuit diagrams component parts lists and description or other information required for the repair of product by qualified personnel Manual SA8810 Rev 5 Table of Contents Quick Start Imstructions scccssssscsssssccssssscessssscessnee 7 Detailed Instructions srrserrrerreerccrrcericercseseseceseseseceneso 9 X1 Threshold Microvolt Approximate Values
4. Ltd Thought Technology Ltd Cimetra LLC 2180 Belgrave Ave 20 Gateway Drive Montreal Quebec Plattsburgh New York Canada H4A 2L8 12901 USA Tel 514 489 8251 Fax 514 489 8255 E Mail mail thoughttechnology com Important Remove batteries prior to shipment Note Remember to remove dead batteries promptly to prevent corrosion damage 20 Repair Return Form Remove and include with unit Name Company Address Phone Date Purchased Model Name Serial on Unit PLEASE STATE PROBLEM 21
5. _ON VOL Lio U Control EMG Home Trainer T User s Manual The Manufacturer Thought Technology Ltd 2180 Belgrave Avenue Montreal Quebec Canada H4A 2L8 Product Name U Control System Product T8800 T8825 T8875 Device Name U Control Incontinence Muscle Re education Unit Device SA8800 SA8825 SA8875 EMERGO EUROPE REP Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 WARNING Type BF Equipment Internally powered equipment Continuous operation Read Instruction Manual Do not use in the presence of a flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide Not to be immersed in water PRECAUTIONS To prevent static discharge from damaging the sensor and or encoders use anti static mats or sprays in your working area A humidifier may also be used to prevent static environments by conditioning hot dry air Sensors damaged by static electricity are not covered under warranty Do not apply any electrode gel or equivalent directly on the sensor snaps Always use electrodes as a medium between the sensor and the client Do not operate U Control Unit within 10 feet of an operating cellular phone similar radio transmitting device other powerful radio interference producing sources such as arc welders radio thermal treatment equipment x ray machines or any other equipment that produces electrical sparks etc ATTENTION To prevent void
6. e not approved and may be unsafe to use Also do not alter or modify the sensor cable and or connector as it may affect the product safety and also will invalidate the warranty For best results keep the sensor cable as short as Keep sensor cable folded possible by folding itina in a tight loop tight loop held with an e clastic or twist tie Hold Q the measuring device close to your body at hip level Instructions for use are included with the sensors 14 IMPORTANT If irritation or discomfort persists discontinue use and notify your physician or health care professional immediately Disposable Uni Gel Electrodes These individual reference electrodes Catalog No T3425 100 snap directly onto the Thought Technology Ltd Extension Surface Cable or the Thought Technology Ltd Vaginal or Rectal sensor reference wires For best results wipe the skin area with a moist cloth before applying the electrode Earphones To use earphone plug earphone into headphone jack located at the top of the Thought Technology Ltd U Control EMG home trainer This will allow for privacy as the sound will only be heard through the earphone 15 Care and Storage of your System The Thought Technology Ltd U Control EMG home trainer is a sensitive piece of equipment and should be handled carefully When removing the sensors from the jacks never pull on any of the sensor cables After use clean the U Control unit by
7. ge refers to the values in microvolts of letters A N on the U Control label X1 Range 0 2 37 5 microvolts i Usually appropriate for pelvic floor muscles na X3 Range 0 6 112 5 microvolts Ideal for large muscle groups xi x3 See the attached scale on pages 12 and 13 for reference microvolt values for different threshold settings 5 10 Second Work Rest Switch Located under the battery panel this switch sets the work and rest cycles at 5 or 10 seconds When set at 5 seconds the light bar will illuminate under the rest arrow on the front panel for 5 seconds and then the light bar will illuminate above the work arrow for 5 seconds The work rest lights will illuminate for 10 seconds when the switch is set at 10 Wrist Strap Use wrist strap to position U Control near the body to avoid breakage and to minimize outside signal interference 11 X1 Threshold Microvolt Approximate Values 12 X3 Threshold Microvolt Approximate Values 13 The Thought Technology Ltd U Control home trainer is designed and approved for use only with the Thought Technology Ltd Vaginal Sensor Catalog No T6050 Thought Technology Ltd Rectal Sensor Catalog No T6051 or the Thought Technology Ltd Extension Surface Cable Catalog No T8820 Any of these sensors will fit the custom sensor jack located on the top panel of the device Use of other manufacturer s sensors with the U Control home trainer ar
8. ing warranty by breaking connector pins carefully align white guiding dot on sensor plug with slot on sensor input Make sure to remove electrodes from sensor snaps immediately after use Apply conductive gel only to electrodes never put gel directly to sensor snaps For best results keep the sensor cable as short as possible by folding it in a tight loop held with an elastic or twist tie Hold the measuring device close to your body at hip level Always use electrodes between the subject and the sensor Do not plug third party sensors directly into instrument inputs Plug only Thought Technology Active Sensor cable connectors into instrument inputs All EMG electrodes and third party sensors must be connected to MyoScan sensors either directly or through an adapter IMPORTANT US Federal Law restricts this device to sale by or on order of licensed health care practitioners All encoders are totally isolated from line 110 or 220VAC power due to battery operation and fiber optic connections to computers However many hospitals and the FDA require that computers printers and any other equipment used with medical devices be electrically isolated from line voltage to UL or CSA medical safety standards Radiated radio frequency electromagnetic fields can cause performance degradation in the U Control Unit In the worst case an RF field strength of 22mV M can cause a degradation of 1uV in the signal from the U Control Unit Be sure
9. ive THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE SOME STATES MAY NOT ALLOW EXCLUSION OF IMPLIED WARRANTIES YOU MAY BE ENTITLED TO ADDITIONAL REMEDIES UNDER STATE LAW THE LIABILITY AND REMEDY STATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF THOUGHT TECHNOLOGY LTD AND REMEDY AVAILABLE TO PURCHASER FOR THIS PRODUCT WHETHER IN CONTRACT TORT INCLUDING NEGLIGENCE OR OTHERWISE AND THOUGHT TECHNOLOGY LTD WILL NOT BE LIABLE TO 19 PURCHASERS FOR ANY SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF ITS HANDLING OR USE SOME STATES DO NOT ALLOW AN EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU THE LIMITED PRODUCT WARRANTY GIVES YOU SPECIAL LEGAL RIGHTS REGARDING THIS PRODUCT AND YOU ALSO MAY HAVE OTHER RIGHTS AGAINST THOUGHT TECHNOLOGY LTD WHICH VARIES FROM STATE TO STATE For repairs or returns Please call the Thought Technology technical support department for a Return Authorization R A number before sending any equipment to us Send the unit postage prepaid and insured with proof of purchase Please provide a detailed description of the problem and write your phone number and address clearly See the form on the following page In U S A Canada and all other countries Thought Technology
10. le Single Electrodes Disposable Uni Gel Electrodes Catalog No T8800 T8825 T6050 T6051 T3402 T3404 T3425 18 Description Includes U Control device with wrist strap mono earplug soft sided carrying case instructions Includes U Control device with wrist strap mono earplug soft sided carrying case instructions Includes 1 vaginal sensor instructions with warranty Includes 1 rectal sensor instructions with warranty 100 foam backed self adhesive triode electrodes 100 foam backed self adhesive single electrodes 100 pre gelled foam backed self adhesive single electrodes Limited Product Warrant Thought Technology Ltd U Control EMG Home Trainer Kit One Year Warranty Thought Technology Ltd warrants to the original purchaser that this product will be free from defects in material and workmanship for a period of one 1 year from the date of purchase If this product proves to be so defective purchaser may return same to Thought Technology Ltd for repair or replacement at Thought Technology Ltd s option All returns must be authorized in advance See PAGE 19 for the number to call for instructions on obtaining authorization and returning this product The liability of Thought Technology Ltd under this limited product warranty does not extend to any abuse or misuse of this product or its repair by anyone other than an authorized Thought Technology Ltd representat
11. ot be used for one month or longer Volume Adjustment eee Turning Unit On M Turn on vol dial clockwise to turn ON VOL L unit on The volume can be Ko increased by continuing to turn the dial clockwise Turning the dial counterclockwise will decrease the volume or turn the unit off Plugging in the earphone allows for privacy and prevents anyone present from hearing any sound Note If unit doesn t work check to ensure that the battery is connected to the proper terminal Setting Threshold Values lt WORK AN The threshold value is set by C a or I rotating the pictured dial until the ie a le ae l desired value appears in the N window next to the word threshold REST The light bar left of the word threshold will illuminate when your muscle activity reaches the threshold level End Panel Controls em om gt ABV CON BIW X1 X3 SENSOR Tone The U Control unit allows the user to designate when a tone will be activated Slide the switch to the desired setting The three choices are as follows ABV A tone is activated when the illuminated light appears next to letters H N or ABOVE threshold ABV CON BLW CON A tone is active CONTINUOUSLY AN caw un BLW A tone is activated when the illuminated light appears next to letters A G or BELOW vii threshold 10 Scale Range The U Control unit offers two choices for range The ran
12. wiping the surfaces with a damp cloth Also use a moistened cotton swab to remove gel from the inside of the electrode connectors for the Thought Technology Ltd vaginal sensor rectal sensor and Thought Technology Ltd extension surface cable This will extend the life of these products For convenient transporting or storage of the U Control device place the device in the enclosed storage bag Attention Static electricity may also damage these products After use the sensor and or electrode may be a potential biohazard Handle and dispose of in accordance with accepted medical practice and applicable local state and national laws and regulations Input Impedance Accuracy Sensitivity Bandwidth frequency CMRR at 60 Hz CMRR gt 90 300 Hz Range Bargraph scaling Current consumption Outputs Battery 1 000 000 MegOhms 5 and 0 3uV lt 0 1 microvolts RMS 90 300 Hz gt 180 dB gt 140 dB 0 2 37 5 microvolts X1 0 6 112 5 microvolts X3 The highest yellow LED is 2 5 times the threshold setting the lowest green LED is 0 2 times the threshold setting other LEDs are proportional to these extremes Approx 15 30 milliamps Earphone 8 32 ohms 2 5 mm mono jack 9 Volt Alkaline or NiCad rechargeable type MN1604 17 Biofeedback Equipment and Accessories Product U Control 50Hz Kit U Control 60Hz Kit Vaginal Sensor Rectal Sensor Disposable Triode Electrode Disposab
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